Department of Acupuncture & Moxibustion, Kyung Hee University Hospitalat Gangdong, #149 Sangil-Dong, Gangdong-Gu, Seoul 134-727, Republic of Korea.
Trials. 2013 Jan 14;14:16. doi: 10.1186/1745-6215-14-16.
Chronic non-specific low back pain is the most common medical problem for which patients seek complementary and alternative medical treatment, including bee venom acupuncture. However, the effectiveness and safety of such treatments have not been fully established by randomized clinical trials. The aim of this study is to determine whether bee venom acupuncture is effective for improving pain intensity, functional status and quality of life of patients with chronic non-specific low back pain.
METHODS/DESIGN: This study is a randomized, double-blinded, sham-controlled clinical trial with two parallel arms. Fifty-four patients between 18 and 65 years of age with non-radicular chronic low back pain experiencing low back pain lasting for at least the previous three months and ≥ 4 points on a 10-cm visual analog scale for bothersomeness at the time of screening will be included in the study. Participants will be randomly allocated into the real or sham bee venom acupuncture groups and treated by the same protocol to minimize non-specific and placebo effects. Patients, assessors, acupuncturists and researchers who prepare the real or sham bee venom acupuncture experiments will be blinded to group allocation. All procedures, including the bee venom acupuncture increment protocol administered into predefined acupoints, are designed by a process of consensus with experts and previous researchers according to the Standards for Reporting Interventions in Clinical Trials of Acupuncture. Bothersomeness measured using a visual analogue scale will be the primary outcome. Back pain-related dysfunction, pain, quality of life, depressive symptoms and adverse experiences will be measured using the visual analogue scale for pain intensity, the Oswestry Disability Index, the EuroQol 5-Dimension, and the Beck's Depression Inventory. These measures will be recorded at baseline and 1, 2, 3, 4, 8 and 12 weeks.
The results from this study will provide clinical evidence on the efficacy and safety of bee venom acupuncture in patients with chronic non-specific low back pain.
This study is registered with the United States National Institutes of Health Clinical Trials Registry: NCT01491321.
慢性非特异性下腰痛是患者寻求补充和替代医学治疗的最常见医学问题，包括蜂毒针灸。然而，随机临床试验尚未充分证实此类治疗的有效性和安全性。本研究旨在确定蜂毒针灸是否能有效改善慢性非特异性下腰痛患者的疼痛强度、功能状态和生活质量。
方法/设计：这是一项随机、双盲、假对照的临床试验，分为两个平行组。将纳入 54 名年龄在 18 至 65 岁之间的非根性慢性下腰痛患者，这些患者在下腰痛持续至少 3 个月，且在筛选时视觉模拟量表（VAS）上的疼痛困扰评分为≥4 分。参与者将被随机分配到真实或假蜂毒针灸组，并按照相同的方案进行治疗，以最大程度地减少非特异性和安慰剂效应。患者、评估者、针灸师和研究人员在准备真实或假蜂毒针灸实验时，对分组分配情况不知情。所有程序，包括根据专家和之前的研究人员的共识设计的预定穴位注射蜂毒增量方案，均按照针灸临床试验报告标准进行设计。使用视觉模拟量表（VAS）测量的疼痛困扰将作为主要结局。使用 VAS 评估疼痛强度、Oswestry 残疾指数、EuroQol 5 维度和贝克抑郁量表评估与腰痛相关的功能障碍、疼痛、生活质量、抑郁症状和不良反应。这些指标将在基线和 1、2、3、4、8 和 12 周进行记录。
本研究的结果将为慢性非特异性下腰痛患者蜂毒针灸的疗效和安全性提供临床证据。
本研究在美国国立卫生研究院临床试验注册处注册：NCT01491321。
